[00:00:05] Speaker 02:
We have four cases on the calendar this morning.

[00:00:08] Speaker 02:
Three patent cases, two from the PTAB and one from a district court.

[00:00:17] Speaker 02:
And a case from the Court of Federal Claims on military pay.

[00:00:24] Speaker 02:
Our first case.

[00:00:27] Speaker 02:
It is Valiant, Omicidicals, Salix, Wyatt, versus Mylan, and Akhtavis.

[00:00:34] Speaker 02:
2018-09-07, Mr. Florence.

[00:00:47] Speaker 00:
Good morning, Your Honours.

[00:00:48] Speaker 00:
May it please the Court, my name is Robert Florence, and I'll be arguing on behalf of the Appellant Mylan today.

[00:00:54] Speaker 00:
We're here today because the district court committed multiple legal errors in finding that there was no tribal issue of material fact with respect to claim 8 of the 025 patent.

[00:01:05] Speaker 00:
Claim 8 is a simple claim.

[00:01:06] Speaker 00:
It's straightforward.

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It requires a solution of methanol trexone or a salt thereof, a pH of between about 3 and about 4, and having 24-month stability at about room temperature.

[00:01:19] Speaker 00:
Because simply claiming the pH and the stability of a known compound should not be a viable invention,

[00:01:24] Speaker 00:
the claim is ripe for a robust and validity-challenged trial.

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However, the District Court cut Mylan off at the knees by taking an unduly myopic view of the evidence and this Court's precedent, resulting in multiple legal errors.

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First and foremost, the District Court substantially changed the claim to require

[00:01:44] Speaker 00:
to support its conclusion with respect to the 24th stability limitation.

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Despite there being no requirement that stability must be achieved by pH alone or without any addition of stabilizers, the district court decided that in fact it did, making no less than 14 statements in the opinion to that effect.

[00:02:07] Speaker 02:
What I gather from the briefs is that you think that Pryorat showed a prima facie case of obviousness of claim eight, right?

[00:02:17] Speaker 00:
That's correct, Your Honor.

[00:02:18] Speaker 02:
And that therefore summary judgment should not have been granted.

[00:02:24] Speaker 02:
If we agree with you that there was a prima facie case, what are the fact questions that should be dealt with on remand?

[00:02:31] Speaker 00:
Sure.

[00:02:32] Speaker 00:
Well, first and foremost, the case should be remanded to apply the proper claim construction because the district court never analyzed the prior art through the lens of the proper construction.

[00:02:41] Speaker 00:
The district court required the prior art to show stability by pH alone, where the claim just doesn't require that.

[00:02:49] Speaker 00:
So that's the first issue.

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And then secondly,

[00:02:52] Speaker 00:
There's a tribal issue of fact as to what the structurally and functionally similar compounds of naloxone and naltrexone show in the prior art in solutions having pH's that overlap with the claimed range here and whether or not those references teach that the stability limitation can be obtained.

[00:03:13] Speaker 00:
And that's the second.

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And then third, there's a tribal issue of fact on Mylan's obviousness theories which were never

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analyzed through the proper claim construction and on the obvious to try theory, which the court did analyze, the court applied the law too narrowly requiring Miland to demonstrate that the pH was the first and foremost

[00:03:36] Speaker 00:
method that APOSA would use to improve stability and not only is that not required by the claim, it's not required by the law because the law requires only there to be finite and known solutions to the problem.

[00:03:48] Speaker 00:
PH adjustment does not have to be the first and foremost solution.

[00:03:53] Speaker 00:
So those are the three main.

[00:03:57] Speaker 02:
Please proceed.

[00:03:58] Speaker 00:
Thank you.

[00:04:01] Speaker 00:
Next, the district court failed to heed this court's precedent by choosing to discount Mylan's prior art references disclosing naltrexone and naloxone, which are closely related and structurally similar to methanol trexone, as I said, in compositions having pHs overlapping the claimed range.

[00:04:18] Speaker 00:
This court has consistently found such structurally and similar compounds to be highly relevant to the obviousness analysis, but the district court here brushed them aside as merely peripheral.

[00:04:29] Speaker 00:
Finally, if time permits, after setting up its unsupportable claim construction, I'd like to point out that the District Court zeroed in on Mylan's obvious to try theory and while applying its unsupportable claim construction and it misapplying the law, the District Court further erred

[00:04:47] Speaker 00:
On that particular point, turning now back to the claim, there's nothing in the claim language, or the patent in fact, that links the pH range to the 24 month duration of stability.

[00:05:02] Speaker 00:
The claim expressly uses the open-ended transitional phrase comprising, and there's no language or limitations in the claim that ban the presence of other stabilizers in the pharmaceutical preparation.

[00:05:14] Speaker 00:
Notably absent from the claim are any limiting phrases such as pH alone or without added stabilizers, all phrases that the district court read into the claim.

[00:05:26] Speaker 00:
But perhaps most importantly, there's nothing in the patent that teaches that stability for the full 24-month duration can even be achieved by pH alone.

[00:05:34] Speaker 00:
There is stability data in the 025 patent, but it's for 12 months.

[00:05:39] Speaker 00:
There's no stability data for 24 months.

[00:05:42] Speaker 00:
Rather, the patent repeatedly encourages skill.

[00:05:45] Speaker 02:
One doesn't need proof in a specification to make a claim.

[00:05:51] Speaker 02:
Of course, if the claim is inoperative, that's not an issue here.

[00:05:57] Speaker 00:
That's correct, Your Honor, and that's not the point that we're making.

[00:06:00] Speaker 00:
The point we're making here is that the patent itself has to be looked at yet.

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The court needed to look at the specification as opposed it would to determine the scope of the claim that's at issue, and the patent itself teaches that in order to obtain the longest duration of stability, there should be a combination of

[00:06:21] Speaker 00:
using pH optimization, also along with stabilizers.

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And in fact, every working example does that very thing.

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So there's nothing in the claim that would exclude a skilled artisan from adding stabilizers to achieve the 24-month duration of stability.

[00:06:38] Speaker 00:
And the district court clearly erred in finding otherwise as evidenced by all the statements that it made while discounting the prior art through the lens of its erroneous construction.

[00:06:48] Speaker 02:
Well, Claim 8 simply recites a result.

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without having anything in the claim that creates that result.

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So that result, if the claim is operative, must have come about from claim one that it depends from.

[00:07:08] Speaker 00:
That's correct.

[00:07:09] Speaker 00:
But there's nothing in claim one either that excludes the use of stabilizers.

[00:07:13] Speaker 00:
It does state that it has a particular pH, but it's not linked to the claim stability.

[00:07:21] Speaker 00:
And the district court's error is evident in how it treated the prior art as it looked at the prior art.

[00:07:27] Speaker 00:
Some of the statements the district court made regarding the Bayhaw reference, the district court declared that the reference does not get the defendants to where they need to go, which is that methanol trexone can be formulated as a solution with 24-month stability with a pH of 3 to 4 without the use of any added stabilizers.

[00:07:47] Speaker 00:
Similarly, regarding the Oschlack reference, the District Court declared that that reference does not at any point disclose the use of pH alone to stabilize naltrexone solutions.

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There are many other statements, but the District Court's error can be summarized

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in the statement where it ultimately concluded that there was no evidence overall that a skilled artisan would have predicted or anticipated success of a formulation using only a pH of three to four to stabilize such a solution.

[00:08:19] Speaker 00:
Yet Mylan was not required to demonstrate

[00:08:23] Speaker 00:
that the court's erroneous claim, pH-only construction was obvious.

[00:08:27] Speaker 00:
Mylan's only required to demonstrate that the properly construed claim is obvious, and it's Mylan's position that the district court construed the claim incorrectly.

[00:08:37] Speaker 00:
Next, based largely on its erroneous construction, the District Court further erred by dismissing as merely peripheral the prior art disclosure of highly similar related compounds with overlapping pH ranges.

[00:08:49] Speaker 00:
This court has long held and in fact recently reaffirmed in the Anacor case that a skilled artisan looking to improve a known compound

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like methanol trexone here, will be highly motivated to study similar compounds with common properties because it's reasonable to assume that they would share other related properties as well.

[00:09:08] Speaker 00:
And in the Anacor case, looking at its earlier law and precedent, this court reiterated that structural similarity alone may be sufficient to give rise to an expectation that compounds similar in structure will also have similar properties.

[00:09:25] Speaker 00:
And the property we're talking about here is stability.

[00:09:28] Speaker 00:
The evidence of record comports perfectly with this court's precedent on this point.

[00:09:32] Speaker 00:
There's ample evidence that methylnaltrexone does indeed have substantial structural similarity to both naloxone and naltrexone.

[00:09:41] Speaker 00:
All three compounds are opioid antagonists.

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They're all derivatives of oxymorphone.

[00:09:47] Speaker 00:
As a result, their structures share a common structural foundation with the only difference being a single substituent on the nitrogen or the amine group.

[00:09:58] Speaker 03:
Myelin's expert chemist, Dr. Hunter opined that... At that point in the composition, are we talking about a finite number of differences?

[00:10:08] Speaker 00:
Between these three molecules, correct.

[00:10:10] Speaker 00:
There's only one substituent that differs.

[00:10:12] Speaker 03:
Not finite, infinite.

[00:10:14] Speaker 03:
Is there an infinite amount of differences?

[00:10:17] Speaker 03:
No, there's not.

[00:10:19] Speaker 03:
If two compositions are not the same, and you're saying that they're similar, is there an infinite number of similar compositions that we're dealing with?

[00:10:29] Speaker 00:
No, no.

[00:10:30] Speaker 00:
Here, we're only dealing with the two pre-existing naloxone and naltrexone oxymorphone derivatives and naltrexone.

[00:10:39] Speaker 02:
The trial court did say there was an infinite number of pH ranges

[00:10:46] Speaker 02:
which can't have been correct.

[00:10:49] Speaker 02:
You're talking about two significant figures, one after the decimal point, which means that there are 10 possibilities between 3 and 4, and even with two figures after the decimal point, 100.

[00:11:04] Speaker 02:
So that infinity comment, surely a finding or whatever it was, was incorrect.

[00:11:12] Speaker 00:
But I absolutely agree with that, Your Honor.

[00:11:15] Speaker 00:
I thought you would.

[00:11:16] Speaker 00:
I don't know how the district court could have arrived to that conclusion.

[00:11:21] Speaker 00:
And if that was true, then every bounded range would always be infinite.

[00:11:26] Speaker 00:
And that's just clearly not the case here.

[00:11:30] Speaker 00:
And I'm not sure if I answered.

[00:11:33] Speaker 00:
Okay.

[00:11:34] Speaker 00:
Thank you, your honor.

[00:11:35] Speaker 00:
And so Mylan's expert chemist, Dr. Hunter, talking about this substantial structural similarity, he said that he testified and opined that a POSA would recognize that properties such as stability of the functional groups that make up these molecules that are the result of the common portions are likely to be shared.

[00:11:54] Speaker 00:
He further opined that under acidic conditions, the pH of the claim here,

[00:12:00] Speaker 00:
The similarities between these three molecules actually increase because it has the effect of protonating the substituent, which is a tertiary amine on the naltrexone and the naloxone, making it even more closely similar to the substituent that's on the methyl naltrexone, which is a quaternary amine.

[00:12:21] Speaker 00:
And he opined that because of these additional similarities when in solution at acidic pH, Opposa would have an even greater expectation that the property of stability would indeed be similar.

[00:12:34] Speaker 00:
Myelin's formulator expert, Dr. Kahn, similarly opined that when developing any formulation, Opposa would generally consider what was known and reported for similar compounds in the prior art.

[00:12:46] Speaker 00:
And in the case here, Opposa would look to other opioid antagonists

[00:12:50] Speaker 00:
and would consider the pH that was found to be suitable for these, such as in naltrexone and naloxone, as evidenced by the Oschlack and the Bayhal references that are in the record.

[00:13:01] Speaker 00:
And Dr. Kahn cited to the well-known treatises Gibson and Remington.

[00:13:06] Speaker 02:
Counsel, you're into your bottle time.

[00:13:07] Speaker 02:
You can continue or save it as you wish.

[00:13:10] Speaker 00:
I will save it.

[00:13:10] Speaker 00:
I'll have it.

[00:13:11] Speaker 00:
All right.

[00:13:12] Speaker 00:
Thank you.

[00:13:12] Speaker 02:
Mr. Diner, is it?

[00:13:15] Speaker 01:
Diner, just like the restaurant.

[00:13:17] Speaker 02:
Diner, right.

[00:13:26] Speaker 01:
Good morning, Your Honors.

[00:13:27] Speaker 01:
Brian Diner for Plaintiffs.

[00:13:29] Speaker 01:
May it please the Court, the judgment below should be affirmed, at least because there is a failure of proof on the reasonable expectation of attaining 24-month stability with no more than 2% degradation.

[00:13:42] Speaker 02:
But look, counsel, we've got a complex molecule here, tricyclic complex nitrogen bridge.

[00:13:54] Speaker 02:
These compounds are in the prior art.

[00:13:57] Speaker 02:
There's nothing novel about the compound.

[00:14:00] Speaker 02:
And what we're talking about is one of these compounds being stable with a pH of three to five.

[00:14:11] Speaker 02:
Three to four.

[00:14:12] Speaker 02:
Well, these are, these pH ranges are in the prior art for compounds of this nature.

[00:14:17] Speaker 02:
Why isn't it clear there was a prima facie case and summary judgment was wrongly granted?

[00:14:23] Speaker 01:
Well, because, Your Honor, it is undisputed on this record that there is no formulation in the prior art on this record that achieved 24-month stability with no more than 2 percent degradation.

[00:14:35] Speaker 01:
And even with, if you assume the pH of 3.2... Well, those are results.

[00:14:40] Speaker 02:
This is a composition.

[00:14:42] Speaker 02:
It's a composition claim.

[00:14:46] Speaker 02:
consisting of a stable pharmaceutical preparation comprising methyl naltrexone at a pH of three to four.

[00:15:00] Speaker 02:
That's all there is of a compound in a solution with a certain pH.

[00:15:08] Speaker 01:
Well, it also requires and recites that there be a 24-month stability for that composition at no more than 2% degradation, and for a composition of matter as well established in this court's law.

[00:15:19] Speaker 02:
But that's a result.

[00:15:21] Speaker 02:
What is there in the claim that brings that about, other than the nature of the composition, the compound?

[00:15:30] Speaker 01:
Well, Your Honor, a composition of matter and its properties are inseparable, as this Court has held all the way back to Inray Papich.

[00:15:38] Speaker 01:
But in addition to that, it is very clear that on this record, just having a pH of 3 to 4 will not give you a necessarily and inevitably a stability of 24 months with no more than 2 percent degradation.

[00:15:53] Speaker 02:
You mean the claim is inoperative?

[00:15:55] Speaker 01:
Absolutely not, Your Honor.

[00:15:57] Speaker 01:
The 025 patent specification is enabling for the claim as written.

[00:16:03] Speaker 01:
It says at column 11, lines 38 to 45, that a stability of 24 months and no more than 2 percent degradation can be attained.

[00:16:14] Speaker 01:
It gives actual test results at column 8.

[00:16:18] Speaker 01:
47 to 58.

[00:16:20] Speaker 01:
It provides a number of teachings and guidance with respect to appropriate buffer systems to get you there.

[00:16:28] Speaker 01:
But importantly, just having a pH of 3 to 4, Your Honors, is not necessarily inevitably going to get you to the claim stability.

[00:16:39] Speaker 01:
They didn't argue in herency.

[00:16:40] Speaker 01:
It's not in their opening brief.

[00:16:41] Speaker 01:
It's waived.

[00:16:42] Speaker 01:
It wasn't developed below.

[00:16:43] Speaker 01:
But if you look at the patent specification, it actually makes clear why this is so.

[00:16:48] Speaker 01:
And it dispels the notion that just having a pH of 3 to 4 will give you the claim stability.

[00:16:53] Speaker 01:
At column 10, lines 27 to 33 of the patent in suit, it says that when you add base to this formulation,

[00:17:02] Speaker 01:
Depends on how you get there, Your Honor.

[00:17:04] Speaker 01:
Just getting two, three, to four doesn't do it.

[00:17:06] Speaker 01:
It teaches you how to get there in a way that will give you stability and avoid destabilizing the compound.

[00:17:13] Speaker 01:
At column 10, lines 27 to 33, it says adding base will destabilize the compound, such as sodium hydroxide.

[00:17:21] Speaker 01:
And Dr. Kahn, my expert.

[00:17:24] Speaker 02:
Adding base raises the pH.

[00:17:26] Speaker 01:
But if you bring it down, for example, in making the formulation, it goes to how it's formulated, to say, by adding excess acid, to say two or one, then you've got to titrate it up with base.

[00:17:37] Speaker 01:
You add sodium hydroxide to it, and it's going to exasperate the degradation, and it's going to destabilize.

[00:17:42] Speaker 01:
Point in fact, it doesn't establish on this record that just having a pH of three to four will get you the claim stability.

[00:17:51] Speaker 01:
And our own specification establishes it enables our invention because it describes our invention and provides information to do so.

[00:17:59] Speaker 01:
But it also establishes that three to four does not necessarily and inevitably get you to the claim stability.

[00:18:08] Speaker 02:
What causes the stability if it's not the compound's inherent properties and the particular pH?

[00:18:18] Speaker 02:
There's nothing else in the claim.

[00:18:21] Speaker 01:
What the patent is teaching, and what Skilled Heart would know when they read that claim in light of the patent specification, is that a pH of 3 to 4, yes, it can get you a loan, the claim stability, but it also teaches and provides guidance

[00:18:38] Speaker 01:
that once you are reading the specification, we know that the way you formulate it is also important, and it provides information and guidance to do that.

[00:18:47] Speaker 01:
As I said, for example, at column nine, most of that column, it gives you information, the skilled person information on the buffer systems that would be appropriate to get the claimed stability of less than 2 percent, or not more than 2 percent degradation at 24 months.

[00:19:04] Speaker 01:
and it also teaches you what to avoid so that you don't have a situation where you just arrive at three to four, but you have degradation that exceeds two percent.

[00:19:14] Speaker 01:
I'd like to go to Mylan's failure proof with respect to that claim limitation, which is a recited limitation and a property of this composition.

[00:19:24] Speaker 01:
The motion was brought to test their evidence, and on this critical limitation on this record, they failed to establish a reasonable likelihood of success of being able to meet the claim limitation of 2 percent, no more than 2 percent degradation.

[00:19:39] Speaker 01:
Their expert's testimony is insufficient on this, both in terms of the expert reports and the deposition of Dr. Khan fares no better.

[00:19:49] Speaker 01:
During his deposition, he made a number of conclusory unsupported statements

[00:19:54] Speaker 01:
to try to argue that accelerated studies, for example, will get you to the claimed pH of 24 months.

[00:20:03] Speaker 01:
But he never mentions, in fact, in that testimony anything about 2 percent degradation.

[00:20:07] Speaker 03:
What about Dr. Hunter?

[00:20:10] Speaker 03:
What did his evidence point to?

[00:20:12] Speaker 01:
Oh, his evidence pointed to the fact that Dr. Kahn's unsupported conclusory statements were not enough, and you actually needed more information.

[00:20:20] Speaker 01:
Because Dr. Hunter said that with respect to Oschlock, one of the references directed to naltrexone, the alleged structure with similar compounds, that none of those examples

[00:20:31] Speaker 01:
met the claimed stability limitation.

[00:20:34] Speaker 01:
And importantly, at 18 months, which is real-time stability, it already had exceeded 2% degradation.

[00:20:41] Speaker 01:
And so Dr. Hunter's testimony actually makes clear that Dr. Khan's testimony needed to have more.

[00:20:48] Speaker 01:
Needed to have more support than just his word that six weeks at 60 degrees C or six months at 40 degrees C and 70% relative humidity automatically gets you to 24 months.

[00:21:01] Speaker 01:
If there was some industry practice or some view in the industry, then they should have provided evidence to support that.

[00:21:09] Speaker 01:
And they didn't.

[00:21:10] Speaker 01:
And that's the point.

[00:21:11] Speaker 01:
That's why they have a failure proof.

[00:21:12] Speaker 01:
That's why that testimony is conclusory, unsupported, and cannot raise a genuine issue of material fact in a context of summary judgment.

[00:21:21] Speaker 01:
And that is clear as a matter of law, both in terms of the biotech case and the in vitro gene case that we cited in our materials.

[00:21:32] Speaker 01:
Now, I'd like to turn to the allegation that the District Court misconstrued claim aid.

[00:21:39] Speaker 01:
It did not.

[00:21:42] Speaker 01:
But before I forget, the first point to make is even if the District Court did misconstrued claim aid and incorporate a pH-only stability requirement, as counsel says, it would not have mattered in this case because they still, for all the reasons I've mentioned, have a failure proof with respect to the 24-month

[00:21:58] Speaker 01:
stability limitation and no more than 2% degradation.

[00:22:02] Speaker 01:
But the district court in Portland, Your Honors, was not interpreting claim eight and certainly wasn't misinterpreting it or misconstruing it.

[00:22:09] Speaker 01:
He was merely responding to the arguments that they made below with respect to what their theory of obviousness was.

[00:22:18] Speaker 01:
in their introduction and often repeated throughout their brief below in their opposition, they say that the pH of three to four is the predictable solution to solve the alleged long-term stability problem.

[00:22:34] Speaker 01:
They say that in the intro.

[00:22:35] Speaker 01:
They say that at joint appendix

[00:22:38] Speaker 01:
393 to 394.

[00:22:39] Speaker 01:
They say that 4003 and 4012.

[00:22:46] Speaker 01:
Not surprisingly, Your Honors, the judge below was responding to their argument of obviousness, the postulated theory of obviousness, when he actually cited at Joint Appendix 31 and then in the paragraph bridging 34 to 35 and 38,

[00:23:03] Speaker 01:
He said, quoting them, arriving at a pH of three to four for stabilizing methylene-altrexone solutions was a predictable result.

[00:23:13] Speaker 01:
He carried that underlying factual premise or proposition that they proposed throughout his discussions with respect to the references.

[00:23:23] Speaker 01:
And what we see, Your Honors, is that he was not saying pH alone.

[00:23:28] Speaker 01:
What he was saying is this is your theory of obviousness.

[00:23:31] Speaker 02:
There's nothing else in the claim

[00:23:33] Speaker 02:
other than pH.

[00:23:37] Speaker 02:
And pH from three to four is well described for Naloxone compounds.

[00:23:46] Speaker 02:
So, clearly there was a prima facie case of obviousness of this compound, which is an old compound, close to others, the claim reciting nothing other than pH.

[00:24:03] Speaker 02:
And in claim eight, a further result in stability for a little longer term than was in the specification.

[00:24:14] Speaker 01:
Respectfully, Your Honor, we would disagree.

[00:24:17] Speaker 01:
In fact, when you look at the pH of three to four and you look at this record to follow up on your thought process there, when you look at this record, it is undisputed on this record with respect to creating a prima facie case that pH had no effect on the stability of these formulations.

[00:24:38] Speaker 02:
There's nothing else in the claim.

[00:24:40] Speaker 02:
Nothing else in the claim.

[00:24:42] Speaker 02:
Claim 8 recites a result of 24-month stability.

[00:24:47] Speaker 02:
That's a result.

[00:24:47] Speaker 02:
There's nothing in claim 8 that causes that stability.

[00:24:53] Speaker 02:
There's no compound there.

[00:24:55] Speaker 02:
There's no stabilizer.

[00:24:57] Speaker 02:
And claim 8 is dependent on claim 1.

[00:25:01] Speaker 02:
which is similarly devoid of anything to cause stability other than either the pH, which is well known for similar compounds, or the nature of the compound itself.

[00:25:16] Speaker 01:
Well, the record evidence in this case, Your Honor, establishes that there would not and could not have been a prima facie case of obvious just because pH was there for structurally similar compounds.

[00:25:26] Speaker 01:
Because the record establishes that those structurally similar compounds, when they isolated pH of pH 3.2 and measured its stability, it actually caused significant destabilization upwards of 20 to 29 percent.

[00:25:40] Speaker 01:
So on its face, it wouldn't have created a prima facie case.

[00:25:43] Speaker 01:
Not only that,

[00:25:44] Speaker 02:
And what caused the lack of stability for these, that you're reciting?

[00:25:51] Speaker 01:
We have a different compound, Your Honor, and they have admitted that.

[00:25:53] Speaker 01:
We have a different compound which has different activity, and that's the reason why it is different, and that's the reason why it performs differently, and we have a 24-month stability limitation with no more

[00:26:05] Speaker 01:
than 2 percent degradation has never been attainable in the prior art before.

[00:26:09] Speaker 01:
And it's because of the differences in the compound.

[00:26:12] Speaker 01:
But as I was saying before, another reason why there couldn't have been a primophagia case on this record, in addition to the fact that when they isolated pH at 3.2, it actually destabilized.

[00:26:23] Speaker 01:
When you look at what Dr. Hunter said with respect to Oschlock,

[00:26:26] Speaker 01:
He already said that none of those examples had to claim stability, and in 18 months of real time, actually showed more than 2 percent degradation.

[00:26:36] Speaker 01:
And so it's a prima facie case, if anything, of non-obviousness, Your Honor, not of obviousness.

[00:26:44] Speaker 01:
And so, as I was saying with respect to this allegation that the district court misconstrued the claim, it was just responding to their position of obviousness and looking for proof out of the record.

[00:26:56] Speaker 01:
He analyzed Formulations 1 and 3 of Bohol, and Formulation 1 is what I was referring to before.

[00:27:02] Speaker 01:
When they isolated pH and measured its stability, it caused substantial degradation.

[00:27:07] Speaker 01:
And when they put in a stabilizer, it somehow cured that degradation.

[00:27:11] Speaker 01:
But the point that you make here or you see here is that it didn't comport with their position of obviousness, their postulated position that pH was going to be the predictable solution.

[00:27:23] Speaker 01:
And the judge was just saying, show me something in this record that supports your theory of obviousness.

[00:27:28] Speaker 01:
Finding none is why he concluded there was not.

[00:27:31] Speaker 01:
a record upon which anyone can conclude that the underlying factual proposition of arriving at a pH of three to four for the long-term stability methyl naltrexone solutions was indeed not predictable based on that evidence.

[00:27:45] Speaker 01:
And if you look, Your Honors, at Joint Appendix, page 40, you will see there at the bottom of that page

[00:27:53] Speaker 01:
sorry, 39 into 40, you will see at the bottom of page 39 that he actually is looking at all the evidence as a whole.

[00:28:00] Speaker 01:
He dismisses their case on obviousness because they didn't prove what they said the prior art did prove.

[00:28:06] Speaker 01:
But then he looked at all the evidence as a whole and he said, optimize pH along with stabilizers and chelators and container systems can be experimented with.

[00:28:17] Speaker 01:
And there, it itself establishes that he understood the claims to be broader via comprising claim, and not restricted.

[00:28:23] Speaker 01:
But then he said, it's just be like when you have all that together, it's just like throwing the metaphorical dots at a target and without any guidance or direction in their art.

[00:28:33] Speaker 01:
And that cannot lead to a privatization piece of obviously.

[00:28:38] Speaker 01:
Thank you, Your Honor, as I believe I'm out of time.

[00:28:40] Speaker 01:
Thank you for your time today.

[00:28:41] Speaker 02:
Thank you, Counsel.

[00:28:43] Speaker 02:
Mr. Florence has some rebuttal time.

[00:28:48] Speaker 02:
Mr. Deina says lack of proof, lack of evidence.

[00:28:52] Speaker 00:
Mylan respectfully disagrees.

[00:28:54] Speaker 00:
The district court clearly required the claim at issue to have a pH-only limitation and then looked at the prior art through that lens.

[00:29:03] Speaker 00:
And once looking at the prior art, the district court declared that, well, there's nothing in the prior art that indicates that you could have the claimed duration of stability based on pH alone.

[00:29:15] Speaker 00:
But that's not what the claim requires.

[00:29:17] Speaker 00:
And I believe what I heard Mr. Diner say more than once during his argument was that he admitted that having a pH of three to four alone will not get you the 24-month stability here that's claimed in the claim.

[00:29:31] Speaker 00:
Well, you can't discount the prior art.

[00:29:33] Speaker 00:
for not being able to do that either based on pH alone when the claim doesn't cover it and they've admitted that they can't do it on pH alone.

[00:29:42] Speaker 00:
What the prior art does show is that in structurally similar compounds, naloxone and naltrexone, having a pH that overlaps with the claimed range and with the addition of stabilizers, you can get

[00:29:55] Speaker 00:
incredibly long durations of claimed stability.

[00:29:58] Speaker 00:
It's correct that the prior art does not disclose 24 months specifically per se.

[00:30:03] Speaker 00:
However, it does disclose accelerated stability data and Dr. Kahn explained and testified on that point that

[00:30:11] Speaker 00:
poses routinely extrapolate estimations of long-term stability from such accelerated stability data and that the FDA allows this in its routine because when an applicant applies for a new drug application with the FDA they don't have long-term stability.

[00:30:26] Speaker 00:
There hasn't been enough time hasn't passed to generate that real-time data so the FDA allows and Dr. Kahn testified based on his own experience that it's allowable to

[00:30:38] Speaker 00:
put the drug under accelerated stability conditions, usually at 40 or to 60 degrees Celsius under a higher amount of humidity, and based on that data, a posa can extrapolate to a longer time period and even here 24 months.

[00:30:56] Speaker 00:
And on this point, the district court gave credit to this argument.

[00:31:01] Speaker 00:
The district court said,

[00:31:05] Speaker 00:
That viewing Bay Hall, now while keep in mind the district court was still viewing Bay Hall through the lens of its erroneous construction, but the district court remarked, if claimate taught that 24-month stability of methanol trexel solutions could be accomplished through the use of sodium edidate, in other words, not just pH, then Mylan might have a good point.

[00:31:25] Speaker 00:
But the point here is the claim doesn't require pH alone, and Bayhal and the other references do indeed teach that through a combination of both pH optimization and the use of stabilizers, you can get longer durations of stability.

[00:31:39] Speaker 00:
So there was a reasonable expectation of success here.

[00:31:43] Speaker 00:
And my time is up.

[00:31:45] Speaker 02:
Thank you, Counsel.

[00:31:46] Speaker 02:
Good reading.

[00:31:48] Speaker 02:
Good book.

[00:31:49] Speaker 02:
Color comprehension.

[00:31:51] Speaker 00:
Thank you, Your Honor.

[00:31:51] Speaker 02:
We'll take the case under revisement.